Tag: Clinical Trial

The new version of ISO14155 arrived! |

23rd of March 2026 ISO published the new version of ISO 14155. Changes include In other words all involved in medical device clinical trials regardless whether pre-market or post-market, interventional or observational should take note of it. https://www.iso.org/standard/83968.html

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ADVERSE EVENT REPORTING UNDER MDR – EASY?

Under MDR Adverse Event reporting is meant to be more straightforward and uniform accross the different EU memberstates, but is that truely the case? One of the topics as discussed during the medical device joined ClinOps and RegNed springmeeting of the NVFG April 2023. Below you find the concerning presentation. Feel free to reach out […]

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COVID-19 CLINICAL EVIDENCE DOWNTIME: HOW TO MAKE USE OF IT!

To date numerous guidances, blogposts, webinars have been published addressing what one must and cannot do in the process of clinical evidence collection due to the COVID-19 pandemic (for overviews see here and here), and with this post I have no intention repeating that, but rather want  to focus on the things we CAN do […]

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